NCT00973934已完成2 期
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Sarah Lisanby4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2002年4月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Hamilton Rating Scale for Depression (HRSD), 24 item
研究概览
简要总结
This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- •Age 18-75
- •Use of effective method of birth control for women of child-bearing capacity
- •Willing and capable of providing informed consent
- •Convulsive therapy clinically indicated
- •Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item)
排除标准
- •Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)
- •Pregnancy
- •History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, or structural brain lesion
- •Presence of devices that may be affected by rTMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- •Breast-feeding
- •History of head trauma with loss of consciousness for greater than 5 minutes
- •History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
- •Vagus Nerve Stimulator implanted
- •History of substance abuse or dependence in past 3 months
- •Failure to respond to an adequate course of ECT in the current depressive episode
- •History of ECT in the past 6 months
结局指标
主要结局
Hamilton Rating Scale for Depression (HRSD), 24 item
时间窗: A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course
次要结局
- Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments(A blinded rater will administer various neurospychologiocal tests at various timepoints (baseline, within 3 days following the MST course and at 2 months following the MST course. Treatment Effect Battery (TEB) will be administered at each MST session.)
- Beck Depression Inventory(A blinded rater will administer the test at Baseline, every Tuesday and Thursady during the treatment course and at the end of the MST course)
研究者
Sarah Lisanby
Professor of psychiatry
Duke University
研究点 (4)
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